Intervention, Dietary, Diabetes, Pregnancy (IDDP)

Dietary Intervention for Obese Pregnant Women - a Randomized Controlled Trial

The aim of this rct -study is to explore the effect of a dietary intervention for overweight (body maas index BMI≥25) and obese (BMI≥30) pregnant women on gestational weight gain and the prevalence of gestational diabetes.

Study Overview

• Status: Completed
• Conditions: Obesity; Dietary Habits; Gestational Diabetes; Gestational Weight Gain
• Intervention / Treatment: Behavioral: Dietary intervention

Detailed Description

Pregnant women are recruited for the study from 18 maternity care clinics in Northern Savo and Northern Karelia area. The participants will be randomized into intervention and control groups. All the participants will have access to the study web-pages, which includes written material of healthy diet during pregnancy as well as all the study material (4 day food records, Three factor eating questionnaire (TFEQ R-18) and Binge Eating Scale (BES)). In addition, intervention group will get two virtual dietary counseling sessions by a dietician. The information on participants' gestational weight gain and the result of oral glucose tolerance tests will be collected by the public health nurses after birth.

• Study Type: Interventional
• Enrollment (Actual): 33
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Finland
  • Joensuu, Finland
    • Antenatal maternity care clinics (n=6)
  • Kuopio, Finland
    • Antenatal maternity care clinics (n=12)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• BMI 25 or higher
• healthy, no chronic medical conditions that can prevent participating to the study
• singleton pregnancy
• first trimester of pregnancy at the time of recruitment

Exclusion Criteria:

• BMI less than 25
• chronic medical conditions
• multiple pregnancy
• pregnancy at second or third trimester at the time of recruitment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention group; Dietary intervention: Written material on healthy diet during pregnancy, 2 virtual dietary counseling sessions given by a dietician. Otherwise basic care and counseling at maternity care clinics.	Behavioral: Dietary intervention; Written material on healthy diet during pregnancy and 2 virtual dietary counseling sessions.
No Intervention: Control group; Written material on healthy diet during pregnancy, otherwise basic care and counseling at maternity care clinics.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational weight gain (GWG)	gestational weight gain (from pre-pregnancy weight until childbirth), measured at maternity care clinic.	immediately after the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gestational diabetes mellitus (GDM)	GDM is measured by the result of an oral glucose tolerance test (OGTT)	immediately after the intervention
Eating habits I	eating habits are measured by 4 day food records	During the intervention up to gestational weeks 36-37
Eating habits II	Eating habits are measured by TFEQ R-18 questionnaire	During the intervention up to gestational weeks 37-42
Eating habits III	Eating habits are measured by Binge Eating Scale (BES)	During the intervention up to gestational weeks 37-42

Collaborators and Investigators

• Sponsor: University of Eastern Finland
• Investigators: Principal Investigator: Reeta Lamminpää, University of Eastern Finland

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2020
• Primary Completion (Actual): October 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 3, 2020
• First Submitted That Met QC Criteria: December 30, 2020
• First Posted (Actual): December 31, 2020

Study Record Updates

• Last Update Posted (Actual): November 29, 2023
• Last Update Submitted That Met QC Criteria: November 28, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Body Weight; Pregnancy Complications; Body Weight Changes; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Weight Gain; Diabetes, Gestational; Gestational Weight Gain
• Other Study ID Numbers: 031220

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No